Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202304665943139 Date of Approval: 28/04/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy and pregnancy outcome of oral metronidazole versus oral clindamycin for treating bacterial vaginosis in pregnancy at Ilorin, Nigeria. A randomized control trial.
Official scientific title Efficacy and pregnancy outcome of oral metronidazole versus oral clindamycin for treating bacterial vaginosis in pregnancy at Ilorin, Nigeria. A randomized control trial.
Brief summary describing the background and objectives of the trial Background: Bacterial vaginosis is one of the common bacterial infections in pregnancy. It is associated with adverse pregnancy outcomes despite being asymptomatic in majority of the patients. Different treatment modalities are available however there is high rate of persistent and relapse of the disease. Thus, the search for an effective treatment option becomes imperative. Aim: to compare the cure rate and pregnancy outcome of using oral metronidazole to oral clindamycin in the treatment of BV in pregnancy among antenatal clinic attendees at UITH Ilorin. Objectives: 1. To determine the prevalence of BV among pregnant women attending antenatal clinic at UITH Ilorin. 2. To determine and compare the cure rate following the use of oral metronidazole to oral clindamycin in the treatment of BV in pregnancy. 3..To determine and compare the feto-maternal outcomes among women treated with metronidazole to clindamycin. 4.To make recommendations on BV in pregnancy based on the outcome of objectives 1,2 and 3 above. Methods: The study will be a randomized control study among 104 participants who will be randomized into either metronidazole or clindamycin treatment group following diagnosis of bacterial vaginosis. Treatment will be offered based on the group that the participants belong to and post treatment testing will be done to evaluate cure. Also, patient with persistent disease will be retreated. All participants will be monitored till delivery. The primary outcome will be the cure rate following laboratory diagnosis and administration of antibiotics while the secondary outcome measures will be measured by pregnancy outcomes such as gestational age at delivery, birth weight, neonatal APGAR scores at first and fifth minutes of life and the need for neonatal intensive care unit admission. Planned Handling of Results: The data will be analyzed using IBM-SPSS (statistical package for social science) statistics version 26.0 software. Charts and frequency tables will b
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 17/04/2023
Actual trial start date
Anticipated date of last follow up 03/11/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 500
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Study group twice daily drug for one week. one week Control group will take flagyl brand of oral metronidazole ( 400mg twice daily for one week) while study group will get oral clindamycin (from globela pharmaceutical company) 300mg twice daily for one week. 52 Active-Treatment of Control Group
Experimental Group Study group oral clindamycin 300mg twice daily for one week one week subject will get oral clindamycin 300mg twice daily for one week 52
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• All consenting pregnant women attending antenatal clinic at the study site between 20 and 26weeks of gestation. • Single live intrauterine foetus • Desire to deliver at the study site. • Use of antibiotics in the preceding two weeks before recruitment into the study. • Allergy to metronidazole or clindamycin • Previous history of preterm birth • Previous and present history of preterm premature rupture of membrane (SPROM) • Patient on cerclage. • Chronic medical disorders that can predispose to preterm birth such as diabetes mellitus, lentiviral infection and hypertensive disorders in pregnancy. • Multiple pregnancy Adult: 19 Year-44 Year 19 Year(s) 44 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/11/2022 University of ilorin teaching hospital ethical review
Ethics Committee Address
Street address City Postal code Country
university of ilorin teaching hospital, P.M.B 1459, Ilorin kwara state, Nigeria. kwara state 240003 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome will be the cure rate following laboratory diagnosis and administration of antibiotic to treat bacterial vaginosis four weeks after treatment, a high vaginal swab will be taking to determine cure.
Primary Outcome The primary outcome will be the cure rate following laboratory diagnosis and administration of antibiotic to treat BV. four weeks
Secondary Outcome The secondary outcome measures will be measured by pregnancy outcomes such as gestational age at delivery, birth weight, neonatal APGAR scores at first and fifth minutes of life, neonatal intensive care unit admission and the presence of any side effects of the drug such nausea, vomiting and diarrhoea. four weeks after treatment, then following delivery.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
university of ilorin teaching hospital university of ilorin teaching hospital, ilorin kwara state. Nigeria kwara state 240003 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded as above as above as above Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor self funded as above as above as above Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ganiyat akera adegboyega ghanak622@gmail.com 08157697396 as above
City Postal code Country Position/Affiliation
as above as above Nigeria registrar
Role Name Email Phone Street address
Public Enquiries ganiyat akera adegboyega ghanak622@gmail.com 08157697396 as above
City Postal code Country Position/Affiliation
Nigeria 240003 Nigeria registrar
Role Name Email Phone Street address
Scientific Enquiries ganiyat akera adegboyega ghanak622@gmail.com 08157697396 as above
City Postal code Country Position/Affiliation
Kwara state Nigeria registrar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes It is intended that de-identified individual trial participant data will be shared upon completion and analysis of result. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol within 12months of completion of study. bacterial vaginosis treatment, bacterial vaginosis in pregnancy
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information